UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038892 |
|---|---|
| Receipt number | R000044266 |
| Scientific Title | Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2019/12/15 |
| Last modified on | 2023/06/19 10:14:12 |
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Basic information
Public title
Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Acronym
Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Scientific Title
Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Scientific Title:Acronym
Cost-effectiveness analysis of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in unresectable/recurrent non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the health economics of EGFR T790M mutant testing after acquired resistance to 1st/2nd generation EGFR-TKI in advanced/recurrent non-small cell lung cancer.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ICER of EGFR T790M mutant testing
Key secondary outcomes
Time to treatment failure (TTF), Overall survival (OS), Cost
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 20 years or older 2) Histological or cytological proven NSCLC 3) EGFR mutation positive 4) After acquired resistance to 1st/2nd generation EGFR-TKI
Key exclusion criteria
1) patients treated with immunocheckpoint inhibitors after acquired resistance 1st/2nd generation EGFR-TKI 2) patients received at least 1 regimen of anti tumor therapy within 3 months prior to initiation of 1st/2nd generation EGFR-TKI treatment 3) complicated by haemophilia 4) complicated by leukaemia 5) complicated by severe heart failure
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Takura |
Organization
The University of Tokyo, Faculty of Medicine
Division name
Medical Economics
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
TEL
+817069363485
value-s@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Hosokawa |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Medical Affairs Division
Zip code
103-8426
Address
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
hosokawa.takafumi.bd@daiichisankyo.co.jp
Sponsor or person
Institute
The University of Tokyo, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Faculty of Medicine, Institutional Review Board
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81358410818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Medical advisor]
Hidehito Horinouchi, Department of Thoracic Oncology, National Cancer Center Hospital
Management information
Registered date
| 2019 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044266
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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